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Senior Compliance Engineer
3 weeks ago
Location:
Onsite - Round Lake, Illinois (60073)
Type:
Contract - (NO C2C OR THIRD PARTY ACCEPTED)
Duration:
6+ months - Opportunity for contract extension long term
Pay Rate
– Negotiable depending on DIRECT-related experience
Work Authorization
- Must be able to work in the U.S. with approved authorization status as a citizen or lawful permanent resident of the United States. Visa Status is not allowed for this role as current or future sponsorship is unavailable.
This role is NOT a validation engineering role
Candidates cannot be allergic to Penicillin or Cephalosporins.
Preferred:
Project management experience
Experience with due diligence, auditing, compliance management, or regulatory experience
Hands-on experience in drug product aseptic manufacturing operations
JOB SUMMARY:
Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System.
Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines, and compendia as requirements.
RESPONSIBILITIES:
Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.
Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness.
Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility
Qualifications:
Experience with pharmaceutical and/or device quality and compliance management systems
Knowledge of cGMP and global regulatory guidelines such as EMA, FDA, and other health agencies.
Knowledge of Six Sigma methodology and LEAN principles.
Education and Experience:
• At least 5 years of directly related experience within the pharmaceutical industry or medical device experience
• BS in Science or Engineering. Advanced degree a plus.
Important information:
To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.
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